View : 633 Download: 0
Immunogenicity and safety of a novel recombinant protective antigen anthrax vaccine (GC1109), a randomized, single-blind, placebo controlled phase II clinical study
- Title
- Immunogenicity and safety of a novel recombinant protective antigen anthrax vaccine (GC1109), a randomized, single-blind, placebo controlled phase II clinical study
- Authors
- Kang, Chang Kyung; Kim, Nak-Hyun; Kim, Chung-Jong; Rhie, Gi-eun; Jo, Su Kyoung; Ahn, Misun; Kang, Jieun; Choe, Pyoeng Gyun; Park, Wan Beom; Kim, Nam-Joong; Oh, Myoung-don
- Ewha Authors
- 김충종
- SCOPUS Author ID
- 김충종
- Issue Date
- 2019
- Journal Title
- VACCINE
- ISSN
- 0264-410X
1873-2518
- Citation
- VACCINE vol. 37, no. 29, pp. 3820 - 3824
- Keywords
- Bacillus anthracis; Recombinant protective antigen anthrax vaccine; Immunogenicity; Safety
- Publisher
- ELSEVIER SCI LTD
- Indexed
- SCIE; SCOPUS
- Document Type
- Article
- Abstract
- Background: The demand on effective and safe anthrax vaccine is increasing as a part of the preparedness for possible bioterrorism in the future. We performed a randomized, single-blind, placebo controlled phase 11 clinical study to evaluate the immunogenicity and safety of a novel recombinant protective antigen (rPA) anthrax vaccine, GC1109, in healthy adult volunteers. Methods: Participants were randomized to experiment groups (0.3 mL, 0.5 mL, and 1.0 mL of GC1109) or placebo group (normal saline 0.5 mL) in 2:2:2:1 ratio. They received respective vaccines intramuscularly at 0, 4 and 8 weeks. Immunogenicity was evaluated by seroconversion rate and geometric mean titer (GMT) of lethal toxin neutralizing assay (TNA) and anti-PA IgG by ELISA. Safety was assessed by laboratory tests, and solicited and unsolicited adverse events on diary cards. Results: 30, 29, 30 participants were randomized to 0.3, 0.5, and 1.0 mL of GC1109 groups, respectively, while 15 to placebo group. 92 participants received all three doses. In per-protocol analysis, TNA GMTs at week 12 were 296.5, 285.2, and 433.2 in the three groups, respectively. Seroconversion rates measured by ELISA were 100% at week 12 in the three groups. Local and systemic vaccine-related adverse events were frequent; however, most of them were mild, and no serious events were observed. Conclusions: A new rPA anthrax vaccine GC1109 was immunogenic after three doses of intramuscular administration, and was well-tolerated. (C) 2019 Elsevier Ltd. All rights reserved.
- DOI
- 10.1016/j.vaccine.2019.05.057
- Appears in Collections:
- 의과대학 > 의학과 > Journal papers
- Files in This Item:
There are no files associated with this item.
- Export
- RIS (EndNote)
- XLS (Excel)
- XML